Clinical Compliance Expert
7 days ago
Overview
Vision Achievement is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our organization, you will be responsible for planning and delivering Life Science consulting engagements related to quality/regulatory affairs infrastructure.
Key Responsibilities
- Plan and deliver Life Science consulting engagements related to quality/regulatory affairs infrastructure
- Develop and implement quality systems planning and implementation, design control, and process validation
- Conduct audits and assessments of design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
- Develop and implement submissions, remediation, clinical evaluation, post-market surveillance, and risk management strategies
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements
Requirements
- Bachelor's degree in Engineering, Science, or a Life Sciences-related field
- Significant experience in RA/QA matters related to medical devices, in vitro diagnostics, pharmaceuticals, and cosmetics
- Experience with auditing design and manufacturing, interpretation and application of codes, regulations, and standards, GMP
- Experience with quality systems planning and implementation, design control, and process validation
- Experience with submissions, remediation, clinical evaluation, post-market surveillance, and risk management
Travel
Ability to travel extensively domestically (25% - 50%). Occasional international travel may be required.
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